Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT03710057
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Known case of Chronic Heart Failure (New York Heart Association (NYHA) functional class II to III)
* Clinically stability (at least for 4 weeks)
* Resting heart rate of more than 70 beats/ min (bpm) as assessed from the 12-lead electrocardiogram.
Exclusion Criteria:
* Hypersensitivity to the active substance or to any of the excipients
* Resting heart rate below 70 beats per minute prior to treatment
* Cardiogenic shock
* Acute myocardial infarction
* Severe hypotension (\< 90/50 mmHg)
* Severe hepatic insufficiency
* Sick sinus syndrome
* Sino-atrial block
* Unstable or acute heart failure
* Pacemaker dependent (heart rate imposed exclusively by the pacemaker)
* Unstable angina
* Atrioventricular Block of 3rd degree
* The combination with a strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone
* The combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties.
* Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT03710057
Study Brief:
Protocol Section:
NCT03710057